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| |  Readministration of Intra-articular Sodium Hyaluronate Injection Effective for OA of the Knee; No Adverse Events: Presented at OARSI By Louise Gagnon MONTREAL -- September 18, 2009 -- An injection of intra-articular bioengineered 1% sodium hyaluronate (IA-BioHA) into the knee relieves pain associated with osteoarthritis (OA) of the knee, as measured by a 50-foot walk test, according to research presented here September 12 at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI). The study was a 26-week extension phase of the Euflexxa for Treatment of Painful Osteoarthritis of the Knee (FLEXX) study -- a 26-week, double-blind, randomised, saline-controlled study of OA of the knee, explained lead investigator Roy D. Altman, MD, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California. At the conclusion of the 26-week FLEXX trial, patients had the option of continuing or ceasing therapy. Of the 588 patients, 433 (73.6%) took part in the extension phase. This included patients who received the active injection (n = 214) and those who received placebo (n = 219). Patients in the extension trial received a weekly injection of IA-BioHA at weeks 26, 27, and 28. They were evaluated post injection at week 41 and week 52 and contacted by phone for progress reports at week 34 or 35. “We showed that the reinjection of [IA-BioHA] was effective,” said Dr. Altman. “Patients didn’t have complete relief of pain, but they did have improvement.” Given that there are reports of increased adverse events with reinjection of other intra-articular hyaluronic compounds, it was a key result that reinjection did not produce additional adverse events, according to Dr. Altman. “It was very safe to give a reinjection, and there were no flares,” he said. No patients indicated they had treatment-emergent adverse events or joint effusion during the extension trial, and there was no difference in rates of adverse events for those patients receiving a first injection compared with those receiving a reinjection. Further analysis will examine why patients in the core study who received the active injection opted to not participate in the extension phase, noted Dr. Altman. “They thought they were doing very well and did not need it anymore, moved out of the [geographic] area, or there was some other reason,” said Dr. Altman. “We think the patients [who opted to continue] thought they were getting benefit or thought they were going to get benefit by entering the extension phase.” Funding for this study was provided by Ferring Pharmaceuticals, Inc. [Presentation title: 26-Week Extension of a 26-Week Trial of Intra-Articular Hyaluronate (Euflexxa) in Osteoarthritis of the Knee (The Flexx Trial). Abstract 503]
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